Study of Sulphoraphane in Chronic Kidney Disease

Chronic Kidney Disease stage4 Clinical Trial

Official title:

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol) in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153174
• Other study ID #: STUDY00002021
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety of the compound sulforaphane that boosts the activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has been shown experimentally to play a role in kidney disease. This drug has been tested in patients with breast cancer who have normal kidney function, but has never been tested in patients with kidney disease. In this study, the investigators will establish a safe dose for patients with chronic kidney disease based on blood levels achieved in patients with normal kidney function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 8, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• eGFR = 20 and <60 ml/min/m2/year, and a decline in eGFR of = 3 ml/min/m2/year in the previous 12 months
• Blood pressure <140/90 mm Hg prior to initiation of sulphoraphane
• stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
• able to provide consent
• able to swallow capsules

Exclusion Criteria:

• significant co-morbid conditions with life expectancy of <1 year
• uncontrolled hypertension
• serum potassium of >5.5 mEq/L at screening
• New York Heart Association Class 3 or 4 heart failure symptoms, known EF =30% or hospital admission for heart failure within the past 3 months
• factors judged to limit adherence to interventions
• current participation in another study
• pregnancy or planning to become pregnant or currently breastfeeding
• history of dementia
• on anticoagulants or immunosuppression
• under treatment for cancer

Related Conditions & MeSH terms

• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sulforaphane
This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-Time Curve (AUC 0-8h) in serum	Sulforaphane drug levels will be measured in serum at 0, 2, 4, and 8 hours.	prior to initial dose on day 7 and 2, 4, and 8 hours post-dose
Primary	Area Under the Concentration-Time Curve (AUC 0-8h) in urine	Sulforaphane drug levels will be measured in urine at 0, 2, 4, and 8 hours.	prior to initial dose on day 7 and 2, 4, and 8 hours post-dose
Primary	Number of participants with an adverse event		day 7